Lubbert 2008.
| Methods | Randomised, placebo‐controlled study | |
| Participants | Setting: multicentre trial, Netherlands. Size: there were 120 patients. Of the 61 in the test group, 9 were lost to follow‐up, leaving 52 patients. Of the 59 in the control group, 7 were lost to follow‐up and 3 did not complete the intervention, leaving 49 patients. Baseline characteristics: 46 males and 6 females in the intervention group and 39 males and 10 females in the control group. Inclusion: over 18 years of age, diaphyseal fracture of the clavicle (Allman group 1), treatment begun within 5 days of trauma. Exclusion: multiple trama, re‐fracture, pathological fracture, open fracture or threatened soft tissue envelope, metaphyseal fracture. |
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| Interventions | All participants were treated non‐operatively with a collar and cuff sling for symptom control. Free arm movements within a range allowed by pain were allowed from day 1. Participants maintained a treatment diary. Test: a LIPUS machine was given to the patients at the first visit. The ultrasound signal was given for 20 minutes a day, for 28 days using coupling gel applied directly over the fracture site. The unit was an Exogen 2000 battery powered Main Operating Unit and a Smith and Nephew Treatment Head Module transducer that delivered an ultrasound signal composed of a 200 µs burst of 1.5 MHz sine waves, with a repetition rate of 1 kHz and a spatial average intensity of 30 mW/cm². Control: a sham device that was externally identical to the LIPUS machine was given to the participants with similar instructions for use. |
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| Outcomes | Follow‐up schedule: 1, 2, 4, 6, 8 weeks.
Primary: patient‐reported subjective clinical fracture healing. Secondary: pain (VAS and painkiller use), operation, adverse events, resumption of sport/professional activities/sport. |
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| Notes | Data from the patients excluded from the study was provided by Pieter Lubbert in personal communication; these allowed an intention‐to‐treat analysis. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "For each participating hospital consecutive numbered transducers were delivered in packs of four." "Randomisation took place at the site of the manufacturer." Comment: Distant block randomisation. |
| Allocation concealment (selection bias) | Low risk | Quotes: "Each hospital supply contained two randomly assigned active transducers and two placebo transducers." "The placebo transducers looked identical..." Comment: Allocation was concealed at a distant site. |
| Blinding (performance bias and detection bias) Patient‐reported measures | Low risk | Quote: "The placebo transducers looked identical..." |
| Blinding (performance bias and detection bias) Objective measures | Low risk | Quote: "The placebo transducers looked identical..." |
| Incomplete outcome data (attrition bias) Patient‐reported measures | High risk | Trial flow diagram presented clearly. Only a per‐protocol analysis was presented |
| Incomplete outcome data (attrition bias) Objective measures | Low risk | Need for operation following delayed or non‐union thoroughly described |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk | No additional biases identified |
| Selection bias (imbalance in baseline characteristics) | Unclear risk | Age and smoking status not separately reported. |